search
Back to results

Home Oxygen Treatment of Childhood Acute Bronchiolitis

Primary Purpose

Bronchiolitis, Viral, Home Nursing

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home oxygen therapy
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis, Viral focused on measuring Bronchiolitis, Viral, Home oxygen therapy, Home Nursing, Outcome and Process Assessment (Health Care), bronchiolitis severity score

Eligibility Criteria

2 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 2-24 months, but age postconception of over 44 weeks.
  2. Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest.
  3. X-ray confirms a viral diagnosis of bronchiolitis
  4. First attack of wheezing
  5. O2 Saturation < 91% room air while arrival to the ER
  6. The baby and his family have a way to return to the ER after discharge
  7. The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine
  8. The baby lives in an environment with no smoking
  9. The baby's family is available by phone
  10. The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of < 4 (see definitions)

Exclusion Criteria:

  1. Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem.
  2. Age since conception is less than -44 weeks.
  3. History of apneas
  4. Bacterial pneumonia suggested by a localized-focal finding on X-ray
  5. Previous wheezing attack
  6. O2 Saturation > 92% on room air
  7. Family has no transportation available follow-up visits
  8. The family lives at a distance greater than 30 minutes drive from the medical facility
  9. The baby was treated with steroids for this attack
  10. There is no continuous monitoring of the baby at home

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Home oxygen therapy

    Arm Description

    Infants with acute bronchiolitis of low to moderate severity will be discharged home with supplemental oxygen and monitored by phone calls and home visits.

    Outcomes

    Primary Outcome Measures

    Rate of hospital readmission within 10 days after discharge with home oxygen
    Readmission to the hospital because of (1) increased oxygen requirement (> 1 L\ minute through the nose) to maintain oxygen saturation of> 92%. (2) event of apnea. 3) feeding of less than 50% of normal with clinical evidence of dehydration, (4) the parents or pediatrician wish remove the child from the study.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2012
    Last Updated
    June 12, 2012
    Sponsor
    Soroka University Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01618175
    Brief Title
    Home Oxygen Treatment of Childhood Acute Bronchiolitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    June 2013 (Anticipated)
    Study Completion Date
    August 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Soroka University Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all population groups, and is usually due to respiratory syncytial virus (RSV) infection. The main cause for hospitalization is often a need for oxygen, but can also include high fever (with a suspected secondary bacterial infection) or increasing respiratory distress. In a minority of cases (some of which can be identified in advance by defining risk groups) a serious illness may develop, including risk of respiratory failure and death. Most cases will just require supplemental oxygen and suction of secretions from the nose (as listed in the recommendations of the American Academy of Pediatrics - AAP). However, this apparently "simple" treatment still requires continued hospitalization. This results in a sharp increase in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent years two studies from developed countries have been published where safety has been demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have not been published yet, for example for populations living in poor conditions. The General Health Services (Klalit) in Israel provides integrated hospital and community health service to the majority of the population living o in our region, thus presenting an opportunity for optimal interventions related to this disease.
    Detailed Description
    Objective: To develop a model of community based safe handling of AB in various communities in southern Israel. Methods: A prospective intervention study examining the safety and health expenditures in infants with AB treated first in hospital but then discharged earlier with home oxygen while monitored in the community. Contribution to the focus areas, and the impact of results on health policy planning: 1) Reducing hospitalization days and general financial savings. 2) Ability to implement these findings to populations with variable socio-economic backgrounds. 3) Prevention of nosocomial infections related morbidity. Innovation and uniqueness in the study: test of this hypothesis precisely in our region, where populations have different socio-economic backgrounds, will build a model that may be suitable for all levels of society.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis, Viral, Home Nursing
    Keywords
    Bronchiolitis, Viral, Home oxygen therapy, Home Nursing, Outcome and Process Assessment (Health Care), bronchiolitis severity score

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    85 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Home oxygen therapy
    Arm Type
    Experimental
    Arm Description
    Infants with acute bronchiolitis of low to moderate severity will be discharged home with supplemental oxygen and monitored by phone calls and home visits.
    Intervention Type
    Device
    Intervention Name(s)
    Home oxygen therapy
    Intervention Description
    Oxygen will be provided using a generator, through nasal prongs at a flow rate up to 1 L/min. During home stay the parents will be guided on how to suspect signs of clinical deterioration. General treatment: If oxygen saturation by pulse oximeter is greater than 92%, the oxygen will be reduced by a quarter liter per minute while monitoring for 15 minutes. If oxygen saturation decreased to less than 92% of the child will remain with the best previous oxygen flow until the next visit. Once the child reaches - 0.06 l / min for 15 minutes, he will will be checked back on room air. Cessation of oxygen therapy: when the oxygen saturation remains above 92% on room air. Every day that no home visit was performed a phone call will be done and follow-up questionnaire will be filled daily, including oxygen saturation registration.
    Primary Outcome Measure Information:
    Title
    Rate of hospital readmission within 10 days after discharge with home oxygen
    Description
    Readmission to the hospital because of (1) increased oxygen requirement (> 1 L\ minute through the nose) to maintain oxygen saturation of> 92%. (2) event of apnea. 3) feeding of less than 50% of normal with clinical evidence of dehydration, (4) the parents or pediatrician wish remove the child from the study.
    Time Frame
    Within 10 days from discharge home with O2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 2-24 months, but age postconception of over 44 weeks. Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest. X-ray confirms a viral diagnosis of bronchiolitis First attack of wheezing O2 Saturation < 91% room air while arrival to the ER The baby and his family have a way to return to the ER after discharge The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine The baby lives in an environment with no smoking The baby's family is available by phone The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of < 4 (see definitions) Exclusion Criteria: Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem. Age since conception is less than -44 weeks. History of apneas Bacterial pneumonia suggested by a localized-focal finding on X-ray Previous wheezing attack O2 Saturation > 92% on room air Family has no transportation available follow-up visits The family lives at a distance greater than 30 minutes drive from the medical facility The baby was treated with steroids for this attack There is no continuous monitoring of the baby at home

    12. IPD Sharing Statement

    Learn more about this trial

    Home Oxygen Treatment of Childhood Acute Bronchiolitis

    We'll reach out to this number within 24 hrs